India mandates QR codes on medicine APIs from next year

The government of India has ruled that all packages of active pharmaceutical ingredients (APIs) will have to have a unique identity carried on QR codes from January 1, 2023.

The new requirement is designed to make it easier to identify falsified batches of API, as well as to track substandard or tampered products back to the producer.

The QR code on every pack level will include a unique product identifier, the name of the API, the name and address of the manufacturer, batch information, the date of manufacturing and expiry and manufacturing or import license numbers.

It will also link to a national database with pricing data controlled by the National Pharmaceutical Pricing Authority.

India's Drug and Technical Advisory Board (DTAB) approved the proposal for mandatory QR code on the APIs in June 2019, saying that it will apply to both imported and domestically produced ingredients, and affect some 2,500 APIs used in Indian pharmaceutical products.

The move ties in with other international efforts to track pharma raw materials, including the introduction of guidelines in Europe in 2015 which also require full traceability of APIs from the start to the end of their supply chain.

India’s requirements actually go further by mandating a barcoding system, while the EU guidelines rely on conventional Good Distribution Practice (GDP) elements, although they do not preclude the use of coding to facilitate raw material traceability.

India also has two regulatory efforts aimed at finished medicines traceability, one targeting exports that has had some major teething troubles that have delayed full implementation, and another for domestic medicines that so far has struggled to get off the ground.